Vifiteh Pkp
⚠️ Moderate Risk
FEI: 3003991573 • Moscow, Moscow g • RUSSIA
FEI Number
3003991573
Location
Moscow, Moscow g
Country
RUSSIAAddress
22 Skobelevskaya Street, , Moscow, Moscow g, Russia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/24/2008 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 4/1/2008 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/1/2008 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/1/2008 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/1/2008 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/8/2008 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 1/8/2008 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/4/2007 | 60CCY53XYLOMETAZOLINE HCL (ADRENERGIC) | New York District Office (NYK-DO) | |
| 12/4/2007 | 66VBZ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/14/2007 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/18/2006 | 62MDA08MENTHOL (ANTI-PRURITIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Vifiteh Pkp's FDA import refusal history?
Vifiteh Pkp (FEI: 3003991573) has 11 FDA import refusal record(s) in our database, spanning from 12/18/2006 to 7/24/2008.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Vifiteh Pkp's FEI number is 3003991573.
What types of violations has Vifiteh Pkp received?
Vifiteh Pkp has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Vifiteh Pkp come from?
All FDA import refusal data for Vifiteh Pkp is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.